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OpenTrials
Completed

NCT Number: NCT01055613

Investigational Multi-purpose Contact Lens Care Solution.

This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must be an adapted contact lens wearer
  • best corrected distance visual acuity must be 20/25 or better in each eye
  • must be wearing their habitual lenses on a daily wear basis
  • must be willing to refrain from swimming during the study

Exclusion criteria

  • any systemic diseases that may interfere with contact lens wear
  • any clinically significant ocular disease
  • any ocular infection
  • use of certain medications
  • any grade 2 or greater slit lamp findings
  • any know sensitivity to marketed contact lens care solutions
  • currently pregnant or lactating
  • monovision corrected

Treatment and study plan

Vistakon Investigational Multi-Purpose Solution I

Device

Multi-purpose contact lens care solution.

ReNu MultiPlus Multi-Purpose Solution

Device

Multi-purpose contact lens care solution

Primary outcomes

  1. Slit Lamp Findings

    Time frame: 3 months

    Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.

  2. Distance Visual Acuity (LogMAR)

    Time frame: Up to 3 Months

    Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
First posted
Jan 25, 2010
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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